Trial Outcomes & Findings for AdaptResponse Clinical Trial (NCT NCT02205359)

NCT ID: NCT02205359

Last Updated: 2023-11-29

Results Overview

The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3797 participants
• Primary outcome timeframe: from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
• Results posted on: 2023-11-29

Participant Flow

Subjects were enrolled between August 2014 and January 2019

After subject enrollment, subjects were first implanted with a Medtronic device compatible with the AdaptivCRT algorithm. After successful implant subjects were randomized.

Participant milestones

Measure	aCRT ON The AdaptivCRT (aCRT) algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled (AdaptivBiV and LV)	aCRT OFF Standard CRT aCRT OFF: CRT device programmed to Nonadaptive CRT
Overall Study STARTED	1810	1807
Overall Study COMPLETED	1117	1096
Overall Study NOT COMPLETED	693	711

Reasons for withdrawal

Measure	aCRT ON The AdaptivCRT (aCRT) algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled (AdaptivBiV and LV)	aCRT OFF Standard CRT aCRT OFF: CRT device programmed to Nonadaptive CRT
Overall Study Death	293	327
Overall Study Lost to Follow-up	182	162
Overall Study Physician Decision	51	53
Overall Study Withdrawal by Subject	167	169

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled (AdaptivBiV and LV)	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device programmed to Nonadaptive CRT	Total n=3617 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 11.1 • n=1810 Participants	65.2 years STANDARD_DEVIATION 11.0 • n=1807 Participants	64.9 years STANDARD_DEVIATION 11.0 • n=3617 Participants
Sex: Female, Male Female	782 Participants n=1810 Participants	786 Participants n=1807 Participants	1568 Participants n=3617 Participants
Sex: Female, Male Male	1028 Participants n=1810 Participants	1021 Participants n=1807 Participants	2049 Participants n=3617 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
NYHA class NYHA class II	881 Participants n=1810 Participants	867 Participants n=1807 Participants	1748 Participants n=3617 Participants
NYHA class NYHA class III	908 Participants n=1810 Participants	912 Participants n=1807 Participants	1820 Participants n=3617 Participants
NYHA class NYHA class IV	21 Participants n=1810 Participants	28 Participants n=1807 Participants	49 Participants n=3617 Participants

PRIMARY outcome

Timeframe: from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)

Population: All randomized subjects

The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation	430 Participants	470 Participants

SECONDARY outcome

Timeframe: from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)

Population: All randomized subjects

All-cause mortality in the aCRT ON group vs the aCRT OFF group

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
All-cause Mortality	293 Participants	327 Participants

SECONDARY outcome

Timeframe: from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)

Population: all randomized subjects

First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Percent of Patients With Interventions for Heart Failure Decompensation	238 Participants	255 Participants

SECONDARY outcome

Timeframe: CCS at 6 month post randomization

Population: All randomized subjects

The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged.

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Clinical Composite Score Improved	1250 Participants	1291 Participants
Clinical Composite Score Unchanged	422 Participants	387 Participants
Clinical Composite Score Worsened	138 Participants	129 Participants

SECONDARY outcome

Timeframe: from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)

Population: All randomized subjects

Occurrence of atrial fibrillation lasting >6 hours in one day

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Atrial Fibrillation	317 Participants	316 Participants

SECONDARY outcome

Timeframe: from baseline to 24M follow up

Population: All randomized subjects

The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score mean at 24M	80.3 score on a scale Standard Deviation 19.7	81.8 score on a scale Standard Deviation 19.0
Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall summary score change from baseline to 24M	16.8 score on a scale Standard Deviation 21.2	16.5 score on a scale Standard Deviation 20.4

SECONDARY outcome

Timeframe: from baseline to 24M follow up

Population: All randomized subjects

The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health.

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Change in Quality of Life Measured by the EQ-5D Mean index score at 24M	0.848 score on a scale Standard Deviation 0.173	0.862 score on a scale Standard Deviation 0.173
Change in Quality of Life Measured by the EQ-5D Mean index score change from baseline to 24M	0.054 score on a scale Standard Deviation 0.190	0.048 score on a scale Standard Deviation 0.180

SECONDARY outcome

Timeframe: from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)

Population: All randomized subjects

All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years

Outcome measures

Measure	aCRT ON n=1810 Participants The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 Participants Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years	1.07 readmissions per 100 patient years	0.93 readmissions per 100 patient years

Adverse Events

aCRT ON

Serious events: 1072 serious events

Other events: 773 other events

Deaths: 293 deaths

aCRT OFF

Serious events: 1073 serious events

Other events: 785 other events

Deaths: 327 deaths

Serious adverse events

Measure	aCRT ON n=1810 participants at risk The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 participants at risk Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Blood and lymphatic system disorders Anaemia	2.3% 41/1810 • Number of events 50 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.6% 47/1807 • Number of events 50 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Anaemia macrocytic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Blood loss anaemia	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Coagulopathy	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Idiopathic CD4 lymphocytopenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Immune thrombocytopenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Iron deficiency anaemia	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.72% 13/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Leukocytosis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Neutropenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Normocytic anaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Pancytopenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Splenomegaly	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Thrombocytopenia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Accelerated idioventricular rhythm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Acute coronary syndrome	0.50% 9/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Acute left ventricular failure	2.3% 41/1810 • Number of events 55 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.3% 42/1807 • Number of events 50 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Acute myocardial infarction	1.7% 31/1810 • Number of events 39 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.3% 42/1807 • Number of events 42 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Angina pectoris	1.5% 28/1810 • Number of events 29 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.3% 23/1807 • Number of events 24 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Angina unstable	0.50% 9/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Aortic valve incompetence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Aortic valve stenosis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arrhythmia supraventricular	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arrhythmic storm	0.33% 6/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arteriosclerosis coronary artery	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arteriospasm coronary	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial fibrillation	7.5% 136/1810 • Number of events 183 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	8.5% 154/1807 • Number of events 202 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial flutter	1.1% 20/1810 • Number of events 26 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.3% 24/1807 • Number of events 29 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial tachycardia	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrioventricular block complete	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Bradycardia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Bundle branch block right	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac amyloidosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac arrest	1.7% 30/1810 • Number of events 31 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 19/1807 • Number of events 20 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac asthma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac discomfort	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure	11.4% 206/1810 • Number of events 305 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	13.4% 242/1807 • Number of events 396 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure acute	2.3% 41/1810 • Number of events 55 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	3.0% 55/1807 • Number of events 67 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure chronic	1.4% 26/1810 • Number of events 34 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 26/1807 • Number of events 26 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure congestive	4.8% 86/1810 • Number of events 144 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	4.2% 76/1807 • Number of events 112 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac flutter	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac perforation	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac sarcoidosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac tamponade	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac valve disease	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac ventricular thrombosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardio-respiratory arrest	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiogenic shock	1.2% 21/1810 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.2% 22/1807 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiomegaly	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiomyopathy	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiopulmonary failure	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiorenal syndrome	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.50% 9/1807 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Chronic left ventricular failure	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Congestive cardiomyopathy	0.22% 4/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary artery disease	1.2% 22/1810 • Number of events 23 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.3% 24/1807 • Number of events 29 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary artery occlusion	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary artery stenosis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary ostial stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary vein stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Heart valve incompetence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Heart valve stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Intracardiac mass	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Intracardiac thrombus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ischaemic cardiomyopathy	0.28% 5/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Left ventricular dilatation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Left ventricular dysfunction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Left ventricular failure	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Mitral valve incompetence	0.72% 13/1810 • Number of events 16 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.2% 21/1807 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Mitral valve stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Myocardial infarction	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Myocardial injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Myocardial ischaemia	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Palpitations	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericardial effusion	1.0% 19/1810 • Number of events 19 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 21 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericardial haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericarditis	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericarditis constrictive	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Prinzmetal angina	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pulseless electrical activity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Right ventricular failure	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Sinus tachycardia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Stress cardiomyopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Supraventricular extrasystoles	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Supraventricular tachycardia	0.66% 12/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.72% 13/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tachyarrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tachycardia	0.55% 10/1810 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.61% 11/1807 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Torsade de pointes	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tricuspid valve incompetence	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tricuspid valve stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular arrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular dysfunction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular dyssynchrony	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular extrasystoles	0.72% 13/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.94% 17/1807 • Number of events 19 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular fibrillation	1.3% 24/1810 • Number of events 27 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 25/1807 • Number of events 29 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular tachyarrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular tachycardia	4.8% 87/1810 • Number of events 127 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	5.1% 92/1807 • Number of events 137 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Congenital, familial and genetic disorders Congenital cardiovascular anomaly	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Congenital, familial and genetic disorders Myocardial bridging	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Congenital, familial and genetic disorders Phimosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Ear canal stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Hypoacusis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Meniere's disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Vertigo	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Vertigo positional	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Adrenal insufficiency	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Cushing's syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Goitre	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Hyperparathyroidism	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Hyperthyroidism	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Hypothyroidism	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Parathyroid disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Thyroid mass	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Thyrotoxic crisis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Cataract	0.44% 8/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Choroidal haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Entropion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Epiretinal membrane	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Eye pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Eyelid ptosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Macular hole	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Optic ischaemic neuropathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Retinal artery occlusion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Retinal detachment	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Vitreous haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Abdominal hernia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Abdominal pain	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Abdominal pain upper	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Alcoholic pancreatitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Anal fissure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Anal skin tags	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Ascites	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Chronic gastritis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Colitis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Colitis ischaemic	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Colitis ulcerative	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Colonic fistula	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Constipation	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Crohn's disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Diarrhoea	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Dieulafoy's vascular malformation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Diverticular perforation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Diverticulum	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenal obstruction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenal polyp	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenal ulcer	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenal varices	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Duodenitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Dysphagia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Enteritis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Enterocolitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Erosive duodenitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Faecaloma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastric antral vascular ectasia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastric perforation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastric ulcer	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastritis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastroduodenal ulcer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.2% 22/1810 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.3% 24/1807 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal necrosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Haematemesis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Haematochezia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Haemorrhoids	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Hiatus hernia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Ileus	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Impaired gastric emptying	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Inguinal hernia	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Intestinal angina	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Intestinal ischaemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Intestinal polyp	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Irritable bowel syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Large intestine polyp	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Malabsorption	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Mechanical ileus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Melaena	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Nausea	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Obstructive pancreatitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal achalasia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal obstruction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal perforation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal rupture	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal spasm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Oesophagitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatic mass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatic pseudocyst	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatitis	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatitis acute	0.33% 6/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatitis chronic	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Peptic ulcer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Rectal haemorrhage	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Rectal prolapse	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Rectal ulcer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Small intestinal obstruction	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Small intestinal perforation	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Umbilical hernia	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Volvulus	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Volvulus of small bowel	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Vomiting	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Adverse drug reaction	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Asthenia	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Chest discomfort	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Chest pain	1.5% 28/1810 • Number of events 33 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 30 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Complication associated with device	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Cyst	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Death	2.6% 47/1810 • Number of events 47 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.5% 45/1807 • Number of events 45 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Facial pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Fatigue	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Gait disturbance	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders General physical health deterioration	0.11% 2/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Generalised oedema	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Hernia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Hypothermia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Impaired healing	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site dehiscence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site extravasation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site haematoma	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site haemorrhage	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site pain	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site swelling	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site ulcer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Infusion site extravasation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Malaise	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device pain	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site calcification	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site discharge	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site extravasation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site irritation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Multimorbidity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Multiple organ dysfunction syndrome	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Necrosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Non-cardiac chest pain	1.2% 22/1810 • Number of events 32 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Oedema	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Oedema peripheral	0.28% 5/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Organ failure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pacemaker generated arrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pelvic mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Peripheral swelling	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Phantom shocks	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Physical deconditioning	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Prosthetic cardiac valve stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Puncture site haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pyrexia	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Stent-graft endoleak	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Sudden cardiac death	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Sudden death	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Systemic inflammatory response syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Unevaluable event	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Vascular stent stenosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Vascular stent thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Bile duct stone	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Biliary colic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Biliary dyskinesia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Biliary-bronchial fistula	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholangitis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholangitis acute	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholecystitis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholecystitis acute	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Cholelithiasis	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Chronic hepatic failure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Congestive hepatopathy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Drug-induced liver injury	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Gallbladder polyp	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hepatic cirrhosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hepatic failure	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hepatic lesion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hepatitis alcoholic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Hypertransaminasaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Jaundice	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Jaundice cholestatic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Liver disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Liver injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Anaphylactic reaction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Contrast media allergy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Drug hypersensitivity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Eosinophilic granulomatosis with polyangiitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Food allergy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Heart transplant rejection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Hypersensitivity	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Solid organ transplant rejection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abdominal abscess	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abdominal infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abdominal sepsis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abdominal wall abscess	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abscess limb	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Abscess oral	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Acarodermatitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Anal abscess	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Appendicitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Arteriovenous fistula site infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Arteriovenous graft site infection	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Arthritis bacterial	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Arthritis infective	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Asymptomatic COVID-19	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bacteraemia	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bacterial infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bacteriuria	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Biliary sepsis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bronchiolitis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bronchitis	0.61% 11/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bronchitis viral	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bursitis infective	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations COVID-19	0.99% 18/1810 • Number of events 18 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.2% 22/1807 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations COVID-19 pneumonia	1.3% 23/1810 • Number of events 23 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.94% 17/1807 • Number of events 17 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Campylobacter infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Catheter site cellulitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Catheter site infection	0.11% 2/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Cellulitis	0.99% 18/1810 • Number of events 19 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Cellulitis staphylococcal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Chest wall abscess	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Chronic sinusitis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Citrobacter infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Clostridial sepsis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Clostridium difficile colitis	0.28% 5/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Clostridium difficile infection	0.28% 5/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Coccidioidomycosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Cystitis	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Dermo-hypodermitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Device related infection	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.50% 9/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Device related sepsis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Diabetic foot infection	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Diabetic gangrene	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Disseminated coccidioidomycosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Diverticulitis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.50% 9/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Diverticulitis intestinal perforated	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Empyema	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Endocarditis	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Endocarditis bacterial	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Endocarditis staphylococcal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Enterobacter bacteraemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Enterococcal bacteraemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Enterococcal infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Epididymitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Erysipelas	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Escherichia bacteraemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Escherichia infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Escherichia urinary tract infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Extradural abscess	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Folliculitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Fournier's gangrene	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gangrene	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gas gangrene	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gastroenteritis	0.33% 6/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gastroenteritis salmonella	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gastroenteritis viral	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Gastrointestinal infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Helicobacter infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Hepatitis B	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Herpes zoster	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Herpes zoster disseminated	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Implant site cellulitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Implant site infection	0.77% 14/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infection	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infection susceptibility increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infectious pleural effusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infective myositis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Influenza	0.55% 10/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Infusion site infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Intervertebral discitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Intestinal sepsis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Large intestine infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Localised infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Lower respiratory tract infection	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Lyme disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Meningitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Metapneumovirus infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Norovirus infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Oral candidiasis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Osteomyelitis	0.44% 8/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Osteomyelitis acute	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Otitis externa	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Paronychia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Perineal abscess	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Periorbital cellulitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Peritonitis	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia	4.6% 84/1810 • Number of events 105 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	4.4% 80/1807 • Number of events 93 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia aspiration	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia fungal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia influenzal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia mycoplasmal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia pneumococcal	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia pseudomonal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia streptococcal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Post procedural pneumonia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Post procedural sepsis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Postoperative wound infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pseudomonas infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pulmonary sepsis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pyelonephritis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pyelonephritis acute	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pyuria	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Rectal abscess	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Respiratory tract infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Rhinovirus infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Salmonella sepsis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Scrotal infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Sepsis	1.7% 30/1810 • Number of events 31 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.2% 39/1807 • Number of events 50 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Septic shock	1.4% 26/1810 • Number of events 27 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.94% 17/1807 • Number of events 17 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Sialoadenitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Sinusitis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Soft tissue infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Staphylococcal abscess	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Staphylococcal bacteraemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Staphylococcal infection	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Staphylococcal sepsis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Streptococcal bacteraemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Streptococcal infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Streptococcal sepsis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Systemic candida	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Tooth abscess	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Upper respiratory tract infection	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Urinary tract infection	1.9% 35/1810 • Number of events 51 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.8% 50/1807 • Number of events 57 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Urinary tract infection bacterial	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Urinary tract infection pseudomonal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Urosepsis	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.89% 16/1807 • Number of events 16 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Vascular device infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Viral infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Viral upper respiratory tract infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Vulval cellulitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Wound infection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Alcohol poisoning	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Anaemia postoperative	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Anastomotic complication	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Animal bite	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Ankle fracture	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Aortic pseudoaneurysm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula maturation failure	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Brain contusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Cardiac vein dissection	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Cardiac vein perforation	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Clavicle fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Complications of transplanted kidney	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Concussion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Contusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Coronary bypass stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Craniocerebral injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Device use issue	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Eye injury	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Face injury	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Fall	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Femoral neck fracture	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Femur fracture	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Fibula fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Gastrointestinal injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Graft thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Head injury	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Hip fracture	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.50% 9/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Humerus fracture	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incisional hernia	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Injury	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Joint dislocation	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Joint injury	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Limb injury	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Lower limb fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Multiple fractures	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Multiple injuries	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Overdose	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Patella fracture	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Periprosthetic fracture	0.11% 2/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Pocket erosion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Post procedural hypotension	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural hypotension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural pneumothorax	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural vomiting	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Rib fracture	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Shunt stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Skin injury	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Skin laceration	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Skull fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Spinal compression fracture	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Spinal fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Spleen contusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Sternal fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Sternal injury	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Stoma complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Stomal hernia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Suture related complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Thermal burn	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Tibia fracture	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Toxicity to various agents	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Traumatic haematoma	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Twiddler's syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Upper limb fracture	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular access malfunction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular access steal syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular graft occlusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular graft stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Wound complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Wrist fracture	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Anticoagulation drug level above therapeutic	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Anticoagulation drug level below therapeutic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Arthroscopy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood bilirubin increased	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood glucose decreased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood magnesium decreased	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood pressure increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood pressure orthostatic abnormal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Catheterisation cardiac	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Clostridium test positive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Colonoscopy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Ejection fraction decreased	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram QT prolonged	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Escherichia test positive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Gram stain positive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Haemoglobin decreased	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Heart rate decreased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Heart rate increased	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Hepatic enzyme increased	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Influenza B virus test positive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations International normalised ratio increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Myocardial necrosis marker increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Streptococcus test positive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Troponin increased	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Weight decreased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Weight increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Adult failure to thrive	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Cachexia	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Dehydration	0.72% 13/1810 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Diabetes mellitus	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.11% 2/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Electrolyte imbalance	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Failure to thrive	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Gout	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Haemochromatosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperglycaemia	0.55% 10/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperkalaemia	0.66% 12/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypervolaemia	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypocalcaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypoglycaemia	0.61% 11/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypokalaemia	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.61% 11/1807 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypomagnesaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyponatraemia	0.28% 5/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.83% 15/1807 • Number of events 18 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypovolaemia	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Lactic acidosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Malnutrition	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Metabolic acidosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Obesity	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Steroid diabetes	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Vitamin D deficiency	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Arthralgia	0.77% 14/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Arthritis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Back pain	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Bursal fluid accumulation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Bursitis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Costochondritis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Fibrosis tendinous	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Flank pain	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Foot deformity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Joint instability	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.44% 8/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Muscular weakness	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Neck pain	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Necrotising myositis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Osteitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 21/1810 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 26/1807 • Number of events 29 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Pain in extremity	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Pathological fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Periarthritis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Scoliosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Spinal pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.11% 2/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Synovial cyst	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Weight bearing difficulty	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma metastatic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of salivary gland	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blepharal papilloma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioneuronal tumour	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intravascular papillary endothelial hyperplasia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.22% 4/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.89% 16/1807 • Number of events 16 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lymphoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic salivary gland cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.11% 2/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Primary myelofibrosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.66% 12/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer stage IV	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sinonasal papilloma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Amnesia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Amyotrophic lateral sclerosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Aphasia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Apraxia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Autonomic nervous system imbalance	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Balance disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Basal ganglia stroke	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Bell's palsy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Brain injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Carotid artery disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Carotid artery occlusion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Carotid artery stenosis	0.44% 8/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Carpal tunnel syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Central nervous system vasculitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cerebral artery embolism	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cerebral haematoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cerebral haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cerebral infarction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cerebrovascular accident	1.2% 22/1810 • Number of events 23 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 25/1807 • Number of events 27 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Cervical radiculopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dementia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Diabetic neuropathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dizziness	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dizziness postural	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dystonia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Embolic cerebral infarction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Embolic stroke	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Encephalopathy	0.72% 13/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Epilepsy	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Facial spasm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Guillain-Barre syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Haemorrhage intracranial	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Headache	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hemiparesis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hepatic encephalopathy	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypercapnic coma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypoaesthesia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypoglycaemic encephalopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypotonia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Intracranial aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Intracranial mass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Intraventricular haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Ischaemic stroke	0.50% 9/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Lacunar infarction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Lateral medullary syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Loss of consciousness	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Metabolic encephalopathy	0.33% 6/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Migraine	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Myelopathy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Nerve compression	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Neurodegenerative disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Paraesthesia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Paraparesis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Paresis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Parkinson's disease	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Peripheral sensory neuropathy	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Polyneuropathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Polyneuropathy chronic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Presyncope	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Quadriplegia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Radicular pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Ruptured cerebral aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Seizure	0.50% 9/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Serotonin syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Spinal claudication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Status epilepticus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Subarachnoid haemorrhage	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Syncope	1.5% 27/1810 • Number of events 32 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 25/1807 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Thalamic infarction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Toxic encephalopathy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Transient ischaemic attack	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Tremor	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Uraemic encephalopathy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Vascular dementia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Wernicke's encephalopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Pregnancy, puerperium and perinatal conditions Delivery	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Pregnancy, puerperium and perinatal conditions Peripartum cardiomyopathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device breakage	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device capturing issue	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device connection issue	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device dislocation	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device electrical impedance issue	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device end of service	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device extrusion	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device failure	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device inappropriate shock delivery	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device lead damage	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device lead issue	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device malfunction	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device occlusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device pacing issue	0.77% 14/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.83% 15/1807 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device power source issue	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device stimulation issue	0.77% 14/1810 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.5% 27/1807 • Number of events 28 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Lead dislodgement	4.0% 72/1810 • Number of events 75 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.9% 53/1807 • Number of events 61 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Oversensing	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Prosthetic cardiac valve malfunction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Stent malfunction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Undersensing	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Adjustment disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Adjustment disorder with anxiety	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Agitation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Alcohol abuse	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Anxiety	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Bipolar disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Completed suicide	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Confusional state	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Conversion disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Delirium	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Delirium tremens	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Depression	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Drug abuse	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Major depression	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Mental disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Mental status changes	0.55% 10/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Psychotic disorder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Schizophrenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Suicidal ideation	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Suicide attempt	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Acute kidney injury	4.8% 86/1810 • Number of events 108 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	4.6% 84/1807 • Number of events 95 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Azotaemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Bladder mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Calculus bladder	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Calculus urinary	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Chronic kidney disease	0.39% 7/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Dysuria	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders End stage renal disease	0.55% 10/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Haematuria	0.72% 13/1810 • Number of events 17 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Hydronephrosis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Incontinence	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Nephrolithiasis	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Nephropathy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Oliguria	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Pelvi-ureteric obstruction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal artery stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal atrophy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal colic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal failure	0.61% 11/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 20 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal haematoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal impairment	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal mass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Ureteric stenosis	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Ureterolithiasis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urethral stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urethral syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urinary bladder polyp	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urinary incontinence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urinary retention	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Urinary tract obstruction	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Breast enlargement	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Breast mass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Ovarian mass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Pelvic pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Penile discomfort	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Prostatitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Uterine prolapse	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Uterovaginal prolapse	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.44% 8/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.7% 30/1810 • Number of events 38 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.5% 28/1807 • Number of events 32 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Asthma	0.17% 3/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Cheyne-Stokes respiration	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 28/1810 • Number of events 35 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.5% 28/1807 • Number of events 40 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.72% 13/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Mediastinal mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 20/1810 • Number of events 21 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 19/1807 • Number of events 24 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.99% 18/1810 • Number of events 18 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 21/1810 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.88% 16/1810 • Number of events 16 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.5% 27/1807 • Number of events 28 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Diabetic foot	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Rash pruritic	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Skin ulcer	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Angioplasty	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Aortic valve replacement	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Arteriovenous fistula operation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Arthrodesis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Carotid endarterectomy	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Carpal tunnel decompression	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Coronary angioplasty	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Coronary artery bypass	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Device therapy	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Finger amputation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Heart valve operation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Hip arthroplasty	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Internal fixation of fracture	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Intervertebral disc operation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Knee arthroplasty	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Medical device implantation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Mesenteric artery stent insertion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Neurostimulator removal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Therapeutic procedure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Surgical and medical procedures Tooth extraction	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic aneurysm	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic aneurysm rupture	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic dissection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic stenosis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.50% 9/1807 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Arterial insufficiency	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Arteriosclerosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Arteriovenous fistula	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Axillary vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Circulatory collapse	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Deep vein thrombosis	0.88% 16/1810 • Number of events 18 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 20/1807 • Number of events 20 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Dry gangrene	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Embolism	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Femoral artery dissection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Haematoma	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertension	0.99% 18/1810 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive crisis	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive emergency	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive urgency	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypotension	2.7% 49/1810 • Number of events 54 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	3.0% 54/1807 • Number of events 64 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypotensive crisis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypovolaemic shock	0.17% 3/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Iliac artery occlusion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Iliac artery stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Intermittent claudication	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Ischaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Jugular vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Lymphoedema	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Malignant hypertension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Microscopic polyangiitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Orthostatic hypotension	0.88% 16/1810 • Number of events 17 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.61% 11/1807 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Pelvic venous thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Penetrating aortic ulcer	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral arterial occlusive disease	1.3% 24/1810 • Number of events 34 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 19/1807 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral artery aneurysm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral artery occlusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral artery stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral artery thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral ischaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral vascular disorder	0.11% 2/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral vein occlusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral venous disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Phlebitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Reperfusion injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Shock	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Shock haemorrhagic	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Subclavian vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Superficial vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Superior vena cava stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Superior vena cava syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Thrombophlebitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Varicose vein	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Varicose vein ruptured	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vascular stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vasculitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vena cava thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Venous stenosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Venous thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Venous thrombosis limb	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.

Other adverse events

Measure	aCRT ON n=1810 participants at risk The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise aCRT ON: CRT device with AdaptivCRT enabled	aCRT OFF n=1807 participants at risk Standard CRT aCRT OFF: CRT device with AdaptivCRT disabled
Blood and lymphatic system disorders Anaemia	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Neutropenia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Accelerated idioventricular rhythm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Acute left ventricular failure	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Acute myocardial infarction	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Angina pectoris	1.1% 20/1810 • Number of events 22 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Angina unstable	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Arrhythmia supraventricular	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial fibrillation	6.5% 118/1810 • Number of events 131 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	5.3% 95/1807 • Number of events 114 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial flutter	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial tachycardia	0.66% 12/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrial thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrioventricular block	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrioventricular block complete	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrioventricular block first degree	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Atrioventricular block second degree	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Bradycardia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Bundle branch block left	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Bundle branch block right	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac discomfort	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure	9.9% 179/1810 • Number of events 236 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	11.5% 208/1807 • Number of events 270 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure acute	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure chronic	0.55% 10/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac failure congestive	1.7% 31/1810 • Number of events 34 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.8% 32/1807 • Number of events 38 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac perforation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac perfusion defect	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiac ventricular thrombosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiomegaly	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Cardiomyopathy	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Chronic left ventricular failure	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Chronotropic incompetence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Congestive cardiomyopathy	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary artery disease	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Coronary artery dissection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Diastolic dysfunction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Extrasystoles	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Heart valve incompetence	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Intracardiac thrombus	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Intrapericardial thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ischaemic cardiomyopathy	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Left ventricular dysfunction	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Left ventricular failure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Mitral valve disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Mitral valve incompetence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Myocardial ischaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Nodal rhythm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Palpitations	0.72% 13/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.72% 13/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericardial effusion	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericarditis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Pericarditis constrictive	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Prinzmetal angina	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Right ventricular failure	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Sinus node dysfunction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Sinus tachycardia	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Supraventricular tachyarrhythmia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Supraventricular tachycardia	0.77% 14/1810 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.1% 19/1807 • Number of events 23 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tachyarrhythmia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tachycardia	0.22% 4/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Torsade de pointes	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Tricuspid valve incompetence	0.06% 1/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular arrhythmia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular extrasystoles	1.4% 26/1810 • Number of events 27 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.2% 21/1807 • Number of events 25 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular fibrillation	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Cardiac disorders Ventricular tachycardia	4.1% 75/1810 • Number of events 103 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	4.5% 81/1807 • Number of events 126 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Vertigo	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Ear and labyrinth disorders Vertigo positional	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Adrenal mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Hyperthyroidism	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Endocrine disorders Hypothyroidism	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Charles Bonnet syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Ocular ischaemic syndrome	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Eye disorders Vitreous haemorrhage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Abdominal distension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Dyspepsia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Large intestine polyp	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Melaena	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Mouth haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Gastrointestinal disorders Rectal haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Adverse drug reaction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Asthenia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Chest discomfort	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Chest pain	0.94% 17/1810 • Number of events 17 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.2% 21/1807 • Number of events 34 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Complication associated with device	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Decreased activity	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Device psychogenic complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Drug intolerance	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Fatigue	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders General physical health deterioration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Gravitational oedema	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site bruising	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site dehiscence	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site discharge	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site erythema	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site haematoma	0.77% 14/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.00% 18/1807 • Number of events 18 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site hypoaesthesia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site inflammation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site oedema	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site pain	0.66% 12/1810 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.77% 14/1807 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site pruritus	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site rash	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Implant site swelling	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device discomfort	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site bruise	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site discharge	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site discomfort	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site erosion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site mass	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site oedema	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site pain	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site paraesthesia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site swelling	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Medical device site vesicles	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Non-cardiac chest pain	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Oedema	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Oedema peripheral	1.5% 27/1810 • Number of events 30 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.9% 34/1807 • Number of events 36 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pacemaker generated arrhythmia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Pacemaker syndrome	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Peripheral swelling	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Phantom shocks	0.11% 2/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
General disorders Unevaluable event	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Drug hypersensitivity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Immune system disorders Hypersensitivity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Bronchitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Candida infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Ear infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Erysipelas	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Implant site infection	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pneumonia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Pulmonary tuberculosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Respiratory syncytial virus infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Sinusitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Skin infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Stitch abscess	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Upper respiratory tract infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Urinary tract infection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Infections and infestations Wound infection	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Cardiac vein dissection	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.44% 8/1807 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Contusion	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Device use issue	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Fall	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site discharge	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site haematoma	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site haemorrhage	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site impaired healing	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Incision site pain	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Post procedural complication	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Post procedural contusion	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Postoperative wound complication	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Procedural pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular access site discharge	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Wound complication	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Injury, poisoning and procedural complications Wound dehiscence	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood pressure decreased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Blood pressure increased	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Body fluid analysis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Breath sounds abnormal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Cardiac murmur	1.5% 28/1810 • Number of events 28 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 12 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Cardiac pacemaker evaluation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Carotid bruit	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Ejection fraction decreased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram QRS complex prolonged	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram QRS complex shortened	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram QT prolonged	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram T wave abnormal	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram abnormal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Electrocardiogram low voltage	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Heart rate increased	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Heart rate irregular	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Heart sounds abnormal	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Investigations Pulmonary arterial pressure increased	0.06% 1/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Dehydration	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperglycaemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperkalaemia	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypervolaemia	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.61% 11/1807 • Number of events 15 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hypokalaemia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Arthralgia	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Muscle twitching	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Neck pain	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Pain in extremity	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Carotid artery aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dizziness	0.72% 13/1810 • Number of events 14 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.66% 12/1807 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Dizziness postural	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Electric shock sensation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypoaesthesia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Hypotonia	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Ischaemic stroke	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Loss of consciousness	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Paraesthesia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Parkinson's disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Phrenic nerve irritation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Presyncope	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Seizure	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Syncope	0.55% 10/1810 • Number of events 10 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.94% 17/1807 • Number of events 19 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Nervous system disorders Transient ischaemic attack	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.33% 6/1807 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device alarm issue	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device capturing issue	0.39% 7/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device deployment issue	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device dislocation	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device electrical impedance issue	0.44% 8/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.39% 7/1807 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device extrusion	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device inappropriate shock delivery	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device issue	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device lead issue	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device malfunction	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device pacing issue	2.4% 43/1810 • Number of events 47 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.2% 40/1807 • Number of events 42 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device power source issue	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Device stimulation issue	8.3% 151/1810 • Number of events 183 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	8.5% 153/1807 • Number of events 192 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Lead dislodgement	0.33% 6/1810 • Number of events 6 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.17% 3/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Oversensing	0.99% 18/1810 • Number of events 19 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.4% 26/1807 • Number of events 30 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Product Issues Undersensing	0.39% 7/1810 • Number of events 7 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Anxiety	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Anxiety disorder	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Psychiatric disorders Panic attack	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Acute kidney injury	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Chronic kidney disease	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Cystitis interstitial	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Renal and urinary disorders Renal impairment	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 31/1810 • Number of events 31 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.5% 28/1807 • Number of events 28 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.50% 9/1810 • Number of events 9 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Hiccups	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Rales	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.28% 5/1807 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Respiratory, thoracic and mediastinal disorders Wheezing	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Pruritus	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Social circumstances Physical assault	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic aneurysm	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic dilatation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Aortic stenosis	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Arteriosclerosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Axillary vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Blood pressure fluctuation	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Deep vein thrombosis	0.44% 8/1810 • Number of events 8 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.61% 11/1807 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Essential hypertension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Giant cell arteritis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Haematoma	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertension	1.7% 31/1810 • Number of events 36 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	1.9% 34/1807 • Number of events 41 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive crisis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive emergency	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypertensive urgency	0.11% 2/1810 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Hypotension	2.3% 41/1810 • Number of events 43 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	2.0% 36/1807 • Number of events 39 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Jugular vein distension	0.22% 4/1810 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Jugular vein thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Labile blood pressure	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Labile hypertension	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Orthostatic hypotension	0.72% 13/1810 • Number of events 13 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.55% 10/1807 • Number of events 11 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral arterial occlusive disease	0.28% 5/1810 • Number of events 5 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral artery stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral vascular disorder	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Peripheral venous disease	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Subclavian artery stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.11% 2/1807 • Number of events 2 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Subclavian vein stenosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Subclavian vein thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.22% 4/1807 • Number of events 4 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Superficial vein thrombosis	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Thrombophlebitis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Thrombosis	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Varicose vein	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vascular insufficiency	0.00% 0/1810 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vasculitis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vasoconstriction	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vein dissection	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Vena cava thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Venous thrombosis	0.06% 1/1810 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.00% 0/1807 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.
Vascular disorders Venous thrombosis limb	0.17% 3/1810 • Number of events 3 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.	0.06% 1/1807 • Number of events 1 • the data were collected from subject randomization until death or study completion, median follow-up 4.9 years (maximum follow-up 8.1 years) The clinical study collected all serious and all system, procedure, and/or cardiovascular related adverse events. Healthcare Utilizations where these AEs occurred were also collected. The Endpoint Adjudication Committee reviewed all applicable Healthcare Utilizations and all study reportable events during the study, assessing outpatient treatment and hospitalizations, to determine HF relatedness and AF relatedness for the study objectives.

Additional Information

Janelle van Wel

CRM

Phone: +3166 273 886 62

Email: janelle.van.wel@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place